Duns Number:319241873
Device Description: a hand-held, battery-powered, electronic instrument designed to measure :1) the temperatur a hand-held, battery-powered, electronic instrument designed to measure :1) the temperature of a patient's ear canal, typically to estimate the internal (core) temperature; and 2) the temperature of the site on the skin (e.g., axilla, forehead), by measurement of body infrared emissions. It typically includes both a skin-surface tip and an intra-aural tip.This device is intended for use in the home or healthcare facility. It is a reusable device
Catalog Number
99652
Brand Name
MEDISANA
Version/Model Number
TM A75
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K102554,K102554
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
c643b9db-a226-4824-a66b-ccc718aae273
Public Version Date
July 15, 2021
Public Version Number
2
DI Record Publish Date
July 18, 2019
Package DI Number
04015588987571
Quantity per Package
10
Contains DI Package
04015588996528
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
cardboard
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |